A drug developer has done a final closing for its latest financing round to advance its new twist on chemotherapy treatment for 60- to 75-year-old patients with secondary acute myeloid leukemia through phase 3 clinical trials. Celator Pharmaceuticals’ treatment involves using established chemotherapy drugs for the condition, but in a novel platform to improve outcomes.
The company raised a total of $39 million, including $6.8 million from previous closings. Valence Life Sciences led the financing round and its managing director Scott Morenstein will get a seat on Celator’s board.
In an interview with MedCity News, Celator CEO Scott Jackson said that its partnership with the Leukemia & Lymphoma Society led to an additional $5 million allocated toward its phase 3 study.
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The Princeton, New Jersey-based treatment developer’s phase 3 clinical study will be a 300 patient, randomized, controlled study comparing CPX-351 to conventional cytarabine and daunorubicin therapy with a primary endpoint of overall survival, according to a company statement.
Its proprietary drug ratio technology platform, CombiPlex, identifies ratios of chemotherapy drugs cytarabine and daunorubicin that will deliver a synergistic benefit, and locks the desired ratio through a drug-delivery method that maintains the ratio in patients, according to a company statement.
The drugs approved for acute myeloid leukemia are few and far between. The last one approved by the U.S. Food and Drug Administration in 2000 was developed by Wyeth (now owned by Pfizer) and was called gemtuzumab ozogamicin. The FDA later pulled it from the market in 2010 over concerns about its safety and because it said it failed to demonstrate clinical benefit to patients enrolled in trials.
Jackson said the chemotherapy drugs that are used in Celator’s patient platform–cytarabine and daunorubicin–have been the standard of care for patients with acute myeloid leukemia for the past 30 years.
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It estimates its initial target patient population for its treatment platform falls somewhere between 3,000 and 3,500. But it expects to expand that in the future when the treatment regimen can be applied to other AML patient populations. It also took a more conservative approach by doing two randomized-controlled phase 2 studies. The company was able to show a statistically significant advantage in survival rates for its treatment platform.
The company’s future is an open question that Jackson has no desire to answer just yet. But the funding is a critical step toward what could be its first product approval.
